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Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)

CompletedPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Pneumococcal Disease

Interventions: V116, Placebo, PCV15, PPSV23, PCV15 - Part B

Countries: United States, Belgium, Chile, France, South Africa, Thailand

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Is infected with HIV
* Is receiving combination anti-retroviral therapy (ART) for ≥6 weeks before study entry with no intended changes to combination ART therapy for 3 months after randomization.
* Is vaccine-naïve

Exclusion Criteria:

* Has a history of opportunistic infections ≤12 months before the first vaccination
* Has a history of noninfectious acquired immune deficiency syndrome-related illness
* Has a history of active hepatitis
* Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 2 (Day 1)
* Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid
* Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Has a coagulation disorder contraindicating intramuscular vaccinations.
* Has a recent illness with fever
* Has a known cancer malignancy that is progressing or has required active treatment \<3 years before enrollment
* Had prior administration of PCV15 or PCV20.
* Is expected to receive any pneumococcal vaccine during the study outside of the protocol
* Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
* Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
* Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine
* Has received any live virus vaccine ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine
* Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.

Locations (20)

Phoenix, Arizona, United States
Washington D.C., District of Columbia, United States
Ft. Pierce, Florida, United States
Orlando, Florida, United States
Kansas City, Missouri, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Brussels, Bruxelles-Capitale, Region de, Belgium
Antwerp, Belgium
Temuco, Araucania, Chile
Providencia, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Paris, France
Paris, Île-de-France Region, France
Bloemfontein, Free State, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Paarl, Western Cape, South Africa
Bangkok, Bangkok, Thailand
Chiang Mai, Thailand